MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORESIGHT ELITE OEM MODULE; HEMFSM10

Model Number	HEMFSM10
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not been returned for evaluation per the rep.The device history record review was completed and all inspections passed with no non-conformances.Product not returned per rep.
Event or Problem Description
It was reported that the hemfsm10 channel 2 sto2 value dropped 15 to 20 points after starting a new patient in hemosphere.They started the case with foresight only and the initial sto2 values for both left and right brain were in the mid 70s.The attending anesthesiologist decided to connect the swan ganz.They turned the hemosphere off and started a new patient.Once the hemosphere came up again the left sto2 channel 1 values were the same 72 to 74 but the right sto2 channel 2 dropped 15 to 20 points.The difference remained the entire case.This was during use.There is no patient injury.There will be no product return per the rep.Patient demographics were requested but unavailable.

• Brand Name: FORESIGHT ELITE OEM MODULE
• Common Device Name: HEMFSM10
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 14879625
• Report Number: 2015691-2022-06465
• Device Sequence Number: 12052797
• Product Code: DXG
• UDI-Device Identifier: 00690103200355
• UDI-Public: (01)00690103200355(11)191219
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K043103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/26/2024
• Device Model Number: HEMFSM10
• Device Catalogue Number: HEMTOM10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown